Much ado over cigarette pack labels and health risk warnings

By Dr. Ananya Mandal, MDOct 4 2017

Cigarette makers to alter health risk warnings on their labels

Soon the US cigarettes companies would be published more blunt statements making people aware of the health risks that arise out of smoking. This came from the 1999 lawsuit that was brought by the federal government.

According to the court, these “corrective statements” or direct health warnings are to be aired from next month on television and also appear in the newspapers. One of the statements for example reads, “Smoking kills, on average, 1,200 Americans every day” while another reads, “Smoking is highly addictive”. One of the statements is to say that they had “intentionally designed cigarettes with enough nicotine to create and sustain addiction”.

Five such statements are to be released. They would appear as 30-second ads on television, the court advised, running once each week for a year, on major networks at prime time. In addition the companies are to run full-page ads in 45 newspapers around the country for the next half year. The ads would be run by Altria Group Inc. - parent company of cigarette-maker Philip Morris USA based in Richmond, Virginia, and Reynolds American Inc. along with several other cigarette makers.

The lawsuit in 1999 had said that the labels and their warnings are not accurate and they are “deceiving the public”. According to Altria the manufacturers have reached an agreement with the U.S. Department of Justice regarding when they would release the ads. Murray Garnick, Altria's executive vice president and general counsel explained that this lawsuit was focusing on the industry’s behavior in the 1950’s and since then the whole industry has undergone a sea change. He added that they are now under the regulations of the FDA and are “focused on the future and, with FDA in place, working to develop less-risky tobacco products.”

FDA plans study on effectiveness of the labels about cigarette smoking risks

The Food and Drug Administration (FDA), this month plans to start an experimental study called “Experimental Study on Warning Statements for Cigarettes Graphic Health Warnings”. This would be a voluntary online consumer study that would gauge the effects of the health risk warnings that are placed on the cigarette labels. The proposal for the study was announced late September 2017 in the Federal Register.

The participants would be assessed if the graphic warnings on the cigarette packs were actually having a greater public understanding regarding the negative health effects of smoking cigarettes.

According to the statement, in 2009, Congress enacted the Tobacco Control Act. This modified the Federal Cigarette Labeling and Advertising Act and it was then that the FDA had issued regulations that all cigarette packs should carry “color graphics depicting the negative health consequences of smoking”. The FDA selected 9 images of these warnings, one of which was mandated to be placed over the labels by the companies. This came into place in June 2011. According to the FDA, this was done to encourage current smokers to kick the habit and discourage minors from starting to smoke. This was taken to court by R.J. Reynolds Tobacco Co. and four other cigarette manufacturers who said that imposition of these warnings violated the First Amendment. According to them, the public already know about the risks and these warnings are deterring consumers from buying a lawful product. The U.S. Circuit Court of Appeals supported the tobacco companies in 2012. In the court ruling (2-1), it was said, “the First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal.” Judge Janice Rogers Brown wrote in delivering the opinion of the court that the, “FDA failed to present any data - much less the substantial evidence required under the [Administrative Procedure Act] - showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates.”

As a response to that the FDA has planned this new study to check for the health impact of these graphic warnings on public understanding.

References

1. Cigarette makers to publish new statements acknowledging health risks
2. http://thehill.com/regulation/healthcare/351171-fda-to-study-warnings-for-cigarette-packaging
3. http://www.cspdailynews.com/print/csp-magazine/article/fda-opens-dialogue-e-cigarettes-harm-reduction
4. http://www.legalreader.com/fda-study-warning-labels-for-cigarette-packs/